Objective: Bisacodyl is a laxative drug used in the treatment of constipation, it is soluble in mineral acids, but it is practically insoluble in water. Therefore, it is very hard task to dissolve bisacodyl in alkaline medium so the objective of this study was the development of proper dissolution method for a new formulation of bisacodyl suppositories in a medium simulated to rectal region. Obviously, most of the bisacodyl suppositories preparation products will yield low percentages of dissolution in the alkaline medium of phosphate buffer pH 7.2.
Methods: Preparation inclusion complex of bisacodyl with the solubilizing agent beta-cyclodextrin then incorporated in a suppository base. The quantitative analysis of bisacodyl in suppositories was carried by a developed and validated high-performance liquid chromatography method.
Results and Discussion: The dissolution rates for the innovated formulation of bisacodyl complexed with beta-cyclodextrin suppositories were in average of 97.5% and the stored suppositories of this formulation maintained their specified physical and chemical properties along the real stability study.
Conclusion: The application of the inclusion complexation technique of bisacodyl with beta-cyclodextrin in the production of suppositories enhances the dissolution rate and improves the stability of suppositories performance.
In this study some generic commercial products of Atorvastatin tablets were evaluated by dissolution test in acid medium by comparing with that of parent drug Lipitor of Pfizer Company. Some of solubilizing agents were studied in formulation of Atorvastatin tablet including; surface active agent and PEG 6000 .The most effective factor was the use of PEG6000 in formulation of Atorvastatin tablet which improved the dissolution and the results of dissolution profile of formulated tablet in this work was bioequivalent to that of Lipitor .The quantitative analysis of this work was performed by using reversed phase liquid chromatography and a proper mixture of mobile phase which give a retention time for Atorvastatin about 6 minutes .
SUMMARY
Disodium edetate (0.01%), either alone or in combination with ascorbic acid (0.1%) was an effective stabilizer for isoprenaline injection B.P. but adjustment to pH 2.8 was necessary. The bubbling of nitrogen through the solution in the ampoule before sealing did not prevent degradation in unprotected solutions.
Solutions sterilized by filtration or by autoclaving for 30 min at 116° were stable for at least 1 year at 5° or 25°.
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